Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis

Last updated: August 2, 2024
Sponsor: Tianjin Medical University Second Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Urologic Cancer

Treatment

Building Organoid-on-chips models

Clinical Study ID

NCT06536725
Organoid-on-chips-PCa
  • Ages > 18
  • Male

Study Summary

This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with visceral metastasis of prostate cancer diagnosed clinically orpathologically;

  2. Age ≥ 18 years old;

  3. ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;

  4. Normal liver and kidney function, serum transaminase ALT<66 U/L, AST<36 U/L, totalbilirubin<22 umol/L, creatinine<106 umol/L, urea nitrogen<6.1 mmol/L; Normal bonemarrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;

  5. Can obtain surgical or biopsy samples;

  6. Patients voluntarily join this study and sign an informed consent form.

Exclusion

Exclusion Criteria:

  1. Patients with severe heart, liver, kidney, and peripheral nervous system diseases,as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemiclupus erythematosus, etc;

  2. Patients who are unable to obtain tissue samples;

  3. Subjects with active pulmonary tuberculosis (TB);

  4. Subjects who are preparing for or have previously undergone tissue/organtransplantation;

  5. Exclusion criteria are not listed, but the researchers believe that patients who arenot suitable to participate in this clinical study.

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Building Organoid-on-chips models
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.

Connect with a study center

  • Tianjin Medical Unversity Second Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

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